Pfizer/Lilly Had Big Ambitions For Tanezumab; Are They Finally Dashed?

Given serious safety questions with tanezumab, the US filing seemed like throwing a Hail Mary; two FDA advisory panels overwhelmingly rejected the proposed risk management plan.

Spiraling football in the sky
Pfizer hopes to get tanezumab to the end zone • Source: Shutterstock

Pfizer Inc. and Eli Lilly and Company have held out hope for approval of their first-in-class nerve growth inhibitor tanezumab in a substantial commercial market despite a serious risk profile that put the clinical trial program on hold and later led it to be scaled back. If tanezumab could win US Food and Drug Administration approval in osteoarthritis pain, where the risk appeared greatest, the companies believed label expansions could follow.

However, a near-term US approval of the biologics license application for osteoarthritis appears unlikely after the FDA's Arthritis Advisory Committee and Drug Safety and Risk Management Advisory Committee took a largely negative view of the risk/benefit profile of tanezumab over a two-day meeting on 24 and 25 March

Read the full article – start your free trial today!

Join thousands of industry professionals who rely on Scrip for daily insights

  • Start your 7-day free trial
  • Explore trusted news, analysis, and insights
  • Access comprehensive global coverage
  • Enjoy instant access – no credit card required

More from Neurological

In Brief: US FDA Delay Sends Biohaven Shares Down

 

The US regulator’s decision has taken Biohaven and investors by surprise, with the reason for a ‘major amendment’ status not clear.

Multiple Launches Help Lilly’s Japan Growth

 
• By 

Lilly saw solid growth for its business in Japan last year on the back of several new launches and is building its obesity and Alzheimer's portfolios in the country.

Lundbeck Lifted By Leap In Migraine Therapy Sales

 
• By 

Vyepti revenues rise by nearly 70% in the first quarter.

Sustainability Key To ABL Bio’s Journey From ‘Good To Great’

 
• By 

Helped by a recent major platform deal with GSK, South Korea's ABL Bio is aiming to build its R&D portfolio with an eye on being acquired in the future. CEO Sang Hoon Lee sat down with Scrip to explain the venture's journey so far and its ambitious roadmap.

More from Therapy Areas

Leo Roars To A Profit In Q1 As Adbry Grows In US

 
• By 

The Danish firm's atopic dermatitis drug is holding its own despite strong competition from Sanofi/Regeneron’s Dupixent.

Multiple Launches Help Lilly’s Japan Growth

 
• By 

Lilly saw solid growth for its business in Japan last year on the back of several new launches and is building its obesity and Alzheimer's portfolios in the country.

Novo Nordisk Looks To Septerna For Oral Obesity Options

 

Deal Snapshot: The Danish drugmaker is partnering with GPCR drug discovery expert Septerna to develop multiple small molecules for cardiometabolic targets.